Selected Publications
See how CERobs consultants have contributed to the pharmaceutical and epidemiology community with selected publications.
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Girman CJ, Ritchey ME, Editors. Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records, Academic Press, Elsevier Sciences, ©2021.
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Rosen EM, Ritchey ME, Girman CJ. Can Weight of Evidence, Quantitative Bias, and Bounding Methods Evaluate Robustness of Real World Evidence for Regulator and Health Technology Assessment Decisions on Medical Interventions? Clinical Therapeutics. 2023 Oct 3:S0149-2918(23)00355-7.
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DiPrete BL, Mavros P, Girman CJ, Breskin A, Brookhart MA. Characterizing imbalance in the tails of the propensity score distribution. Am J Epidemiol 2023; 30: 99.
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Wang J, Ritchey ME, Reynolds K, Carbonneau M, Carrera A, Goti N, Horn JR, Girman CJ. Assessment of Codispensing Patterns of Mirabegron and Prespecified CYP2D6 Substrates in Patients with Overactive Bladder. Drugs Real World Outcomes. 2023 Sep; 10(3):439-446. DOI: 10.1007/s40801-023-00370-6
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Zhang X, Brind’Amour K, King KE, Hartmaier S, Harris K, Weinstein DA, Girman CJ. Strategy for generating blinded evidence for single-arm trials with external controls using expert review of home video. Ther Innov Reg Sci 2023 Aug; https://doi.org/10.1007/s43441-023-00568-4
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Zhuo J, Lama S, Knapp K, Gutierrez C, Lovett K, Thai S, Craig GL. Epidemiology and clinical characteristics of interstitial lung disease in patients with rheumatoid arthritis from the JointMan database. Sci Rep 2023 Jul; 13(1):11678. https://doi.org/10.1038/s41598-023-37452-y
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Chandran M, Brind'Amour K, Fujiwara S, Ha YC, Tang H, Hwang JS, Tinker J, Eisman JA. Prevalence of osteoporosis and incidence of related fractures in developed economies in the Asia Pacific region: a systematic review. Osteoporos Int. 2023 Jun; 34(6):1037-1053. doi: 10.1007/s00198-022-06657-8.
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Iglay K, Bennett D, Kappelman MD, Zhang X, Aldridge M, Karki C, Cook SF. A Systematic Review of Epidemiology and Outcomes Associated with Local Surgical and Intersphincteric Ligation Procedures for Complex Cryptoglandular Fistulas. Adv Ther 2023 May; 10.1007/s12325-023-02452-x
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Ritchey ME, Wang J, Young JC, Chandra R, Carrera A, Goti N, Horn JR, Girman CJ. CYP2D6 substrate dispensing among patients dispensed mirabegron: An administrative claims analysis. Drugs Real World Outcomes 2023 Mar; 10(1): 119-129. DOI: 10.1007/s40801-022-00339-x
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Zhang X, Lewandowska M, Aldridge M, Iglay K, Wolford E, Shapiro A. Global epidemiology of factor XI deficiency: A targeted review of the literature and foundation reports. Haemophilia. 2023 Mar; 29(2):423-434. doi: 10.1111/hae.14687
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Thai S, Zhuo J, Zhong Y, Xia Q, Chen X, Bao Y, Dhanda D, Priya L, Wu J. Real-World Treatment Patterns and Healthcare Costs in Patients with Psoriasis Taking Systemic Oral or Biologic Therapies. J Dermatolog Treat 2023; 34(1), 2176708. https://doi.org/10.1080/09546634.2023.2176708
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Weinstein EJ, Ritchey ME, Lo Re III, V. Core Concepts in Pharmacoepidemiology: Validation of Health Outcomes of Interest Within Electronic Healthcare Databases. Pharmacoepidemiol Drug Saf. 2023 Jan; 32(1):1-8. DOI: 10.1002/pds.5537
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Iglay K, Bennett D, Kappelman MD, Reynolds K, Aldridge M, Karki C, Cook SF. A systematic review of epidemiology and outcomes of Crohn's disease-related enterocutaneous fistulas. Medicine (Baltimore). 2022 Nov 11;101(45):e30963. doi: 10.1097/MD.0000000000030963.
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Dahlberg S, Chang E, Weiss S, Dopart P, Gould E, Ritchey ME. Use of Contrave®, naltrexone with bupropion, bupropion, or naltrexone and major adverse cardiovascular events: a systematic literature review. Diabetes Metab Syndr Obes. 2022 Sep 29;15:3049-3067. DOI: 10.2147/DMSO.S381652
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Girman CJ, Ritchey ME, Lo Re III, V. Real world data: Assessing electronic health records and medical claims data to support regulatory decisions for drug and biological products: Commentary from ISPE. Pharmacoepi Drug Saf 2022 Jul;31(7):717-720. doi: 10.1002/pds.5444
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Girman CJ, Panaccio MP, Hayes K, Niewoehner J, Wan GJ. Pain and fatigue improvements in patients treated with repository corticotropin injection across 5 indications: A narrative review. Advances in Therapy 2022 Jul; 39(7):3072-87
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Webster-Clark M, Mavros P, Garry E, Stürmer T, Shmuel S, Young J, Girman C. Alternative analytic and matching approaches for the prevalent new user design: A simulation study. Pharmacoepi Drug Saf 2022 Jul; 31(7):796-803. doi: 10.1002pds.5446.
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Epstein R, Nelms J, Moran D, Girman C, Huang H, Chioda M. Treatment patterns and burden of myelosuppression in patients with small cell lung cancer: SEER-Medicare study. Canc Treat Res Comm 2022 Apr; 31:doi.org/10.1016/j.ctarc.2022.100555
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Rajan P, Iglay K, Rhodes T, Girman C, Bennett D, Kalantar-Zadeh K. Risk of Bias in Non-Randomized Observational Studies Assessing the Relationship between Proton Pump Inhibitors and Adverse Kidney Outcomes: A Systematic Review. Ther Adv Gastroenterology, 2022 Feb 10; 15:17562848221074183. doi: 10.1177/17562848221074183.
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Iglay K, Bennett D, Kappelman MD, Thai S, Aldridge M, Karki C, Cook SF. A Systematic Review of the Patient Burden of Crohn’s Disease-related Rectovaginal and Anovaginal Fistulas. BMC Gastroenterology 2022 Jan; 22, 36. https://doi.org/10.1186/s12876-021-02079-8
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Hartmaier SL, Rhodes T, Cook SF, Schlusser C, Chen C, Han S, Zach N, Murthy V, Davé S. Qualitative measures that assess functional disability and quality of life in ALS. Health Qual Life Outcomes. 2022 Jan 21;20(1):12. doi: 10.1186/s12955-022-01919-9. PMID: 35062955; PMCID: PMC8781297.
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Girman CJ, McNeill AM, Ritchey ME, Andersson Sundell K, Meyer RJ. Demonstrating Real-World Evidence is fit for purpose to support labeling: Parallels in pursuing labeling claims for patient reported outcomes. Ther Innov Reg Sci 2021 May; 55:561-567. DOI: 10.1007/s43441-020-00252-x
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Kennelly MJ, Rhodes T, Girman CJ, Thomas E, Shortino D, Mudd PN Jr. Efficacy of Vibegron and Mirabegron for Overactive Bladder: A Systematic Literature Review and Indirect Treatment Comparison. Adv Ther. 2021 Nov;38(11):5452-5464. doi: 10.1007/s12325-021-01902-8. Epub 2021 Sep 18. PMID: 34537953; PMCID: PMC8520873.
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Ritchey ME, Girman CJ. Evaluating the feasibility of using electronic health records or administrative claims for specific research questions or regulatory purposes. Ther Innov Reg Sci 2020 Nov; 54(6):1296-1302. doi.org/10.1007/s43441-020-00139-x.
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Christian JB, Brouwer ES, Girman CJ, Bennett D, Davis KJ, Dreyer NA. Masking in Pragmatic Trials: Who, What and When to Blind. Ther Innov & Reg Sci 2020; doi.org/10.1177/2168479019843129
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Neuman MD, Kappelman M, Israel E, Ellenberg S, Girman CJ, Robb J, Rabinowitz A, Trontell A. Real-World Experiences with Generating Real-World Evidence: Case Studies from PCORI’s Pragmatic Clinical Studies Program. Contemp Clinical Trials 2020 Nov; 98: 106171. doi: 10.1016/j.cct.2020.106171.
Pragmatic Randomized Clinical Trials
Using Primary Data Collection and Electronic Health Records
1st Edition - April 8, 2021
Editors: Cynthia J. Girman, Mary E. Ritchey
Language: English
Paperback ISBN: 9780128176634
eBook ISBN: 9780128176641